This webinar will examine the FDA’s latest draft guidance, “510(k) Third Party Review Program, Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations” and the important areas for regulated companies to focus in the coming year onward.

The 510(k) Third Party (3P) Review Program (formally known as the Accredited Persons (AP) Program) is authorized under section 523 of the Federal Food, Drug, and Cosmetic (FD&C) Act. Under this authority, FDA recognizes third parties to review premarket notification (510(k)) submissions and recommend the initial classification of certain devices. This establishes a process for recognition of qualified third parties to conduct the initial review of 510(k) submissions for certain low-to-moderate risk devices eligible for review under the 3P Review Program.

This webinar will also discuss amendments made to section 523 by the FDA Reauthorization Act of 2017, which directed FDA to issue draft guidance on the factors that are used to determine what class I or class II devices are eligible for review by an accredited person. The 3P Review Program is intended to enable FDA to focus its internal scientific review resources on higher-risk and complex devices, while maintaining a high degree of confidence in the review of low-to-moderate risk and less complex devices by 3P Review Organizations, and to provide manufacturers of eligible devices a voluntary alternative review process that may yield more rapid decisions on 510(k)s than from FDA.

Areas Covered in the Session :

The 3P Review Process

The 9 Current FDA-Accredited 3P “Persons”

Accredited Persons’ Qualifications

General Categories of Device Subject to 3P

Sites for Specific Elgible Device Listings

Information Required

Important exceptions

Pros and Cons, Considerations

Who Should Attend:

Quality Assurance Departments

Regulatory Affairs Departments

Research and Development Departments

Manufacturing Departments

Engineering Departments

Operations Departments

Production Departments

Consultants

MD2782

John E. Lincoln

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis.

He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.

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